Fixed Distal Femoral Cut Guide, Klassic ONE

GUDID 00819251026260

Fixed Distal Femoral Cut Guide, 5 degrees

TOTAL JOINT ORTHOPEDICS, INC.

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Primary Device ID	00819251026260
NIH Device Record Key	c3ed1f54-1c3f-4ce4-a034-5875aaf4739a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fixed Distal Femoral Cut Guide, Klassic ONE
Version Model Number	2156.00.005
Company DUNS	078416717
Company Name	TOTAL JOINT ORTHOPEDICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com
Phone	+1(801)486-6070
Email	udi@tjoinc.com

Device Dimensions

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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819251026260 [Primary]

FDA Product Code

LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT